The Toxic Substances Control Act (TSCA) has long been the primary law that specifies how industry must manage chemicals and other toxic substances. President Obama has now signed into law revisions that form the first comprehensive changes to TSCA in 40 years. Now that the changes are law, it becomes the responsibility of industries to understand and comply with the new legislation.

Changes to TSCA have been long-awaited, and address a number of omissions or shortcomings of the initial content. Some of the primary changes:

Definitions contained in the bill are deemed as granting more control on behalf of the EPA to interpret such terms as “conditions of use” and “potentially exposed or susceptible subpopulation” for relevance when considering how a substance is made or used, and the inherent risks presented to populations. This enables the EPA to evaluate appropriate control actions required.

Testing of chemicals extends EPA authority in the use of orders and agreements that can be required in the development of hazard and exposure information along with test rules in order to set priorities for chemicals. The EPA is required to explain their reasons and justification for such actions.

The EPA is now required to expedite action when information indicates a significant human risk. In the past, TSCA limited such expediting to those substances that were linked to cancer, birth defects, or genetic mutations.

Further changes require the EPA to reduce or, if possible, replace testing on vertebrate animals and put together a strategic plan to advance the use of test methods that are not based on such vertebrate animals.

Manufacturing and processing sections of the new TSCA address new chemicals and significant new use (SNU) of existing chemicals or substances. The EPA is now obligated to review such developments, categorize them into three groups, and take appropriate action based on the category determined:

  • New chemical or SNU does present an unreasonable risk to the environment, injury, or health
  • Information is insufficient to make a reasonable evaluation of risk, the substance may present an unreasonable risk, there will be production in such significant quantities, or that may exist in the environment in such quantities that a substantial risk to human exposure may exist
  • The chemical or SNU is NOT likely to present an unreasonable risk.

Further sections of the reformed TSCA refer to:

  • EPA responsibilities to maintain controlled chemical inventory lists (currently over 83,000 substances are contained in the list).
  • Further requirements on record-keeping and reporting on the part of importers, distributors, processors, and manufacturers of chemical substances.

How Do the TSCA Changes Impact Business?

New levels of record-keeping in the use and distribution of chemicals will be imposed on industry. It will be critical to comply with these regulations to avoid penalties or restrictions.

Reviews required on the part of the EPA are expected to stretch the limits of existing personnel to the point of delays in approvals or the conducting of evaluations. This could particularly impact companies that manufacture chemicals in acquiring approvals for marketing new substances. Companies bringing new products to market will want to expedite their requests for evaluations to obtain approvals as early as possible.

On the positive side for business, the new legislation preempts state restrictions on chemical distribution and use, putting a more uniform code in place that previously allowed states to draw their own conclusions and limitations of use. Prior limitations by states will be grandfathered as current law, but new chemicals will not be subject to restrictions by individual states. There are limitations in place for these exceptions, placing some level of potential restrictions on manufacturing or distributing within state authority.

There will certainly be more implications to be discovered as the new TSCA details are examined closely.

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